‘All drugs need to be safe and efficacious’ is an ideal goal and the objective of the pharmaceutical industry, researchers and the regulatory agencies is to come closer to this goal as much as possible. In the public health scenario the concepts of drug safety takes a higher priority due to a wider application of therapeutics outside of a controlled environment of clinical trials with rare and idiosyncratic effects surfacing with experience.
According to the dictionary definition, the word vulnerable means someone who is “exposed to the possibility of being attacked or harmed, either physically or emotionally”. So who constitutes the vulnerable population in Clinical Research and why do we need to protect them? To answer this question first, let’s take a brief look at the history of research abuse.
Informed Consent in clinical trial is often the most important part of clinical trial and sometimes neglected too, resulting in serious consequences, for the patient, the doctor involved in the trial and the pharmaceutical company sponsoring the trial. Which brings us to the question of what exactly is an Informed Consent Procedure? It is process wherein the patient is made known details about the clinical trial and is asked whether he / she is willing to participate in the trial voluntarily. Doctors have a duty to fully explain the risk and the consequences of the participating in the clinical trial to the potential subject. Informed consent in a term used both in medical and legal terms.
Clinical Pharmacology is defined as the study of the effects of drugs in human beings and Pharmacoepidemiology falls under the category of Clinical Pharmacology.
Malaria continues to be widespread disease in killing more than 2 million people annually in Africa. The sub Saharan desert registers the most number of cases of malaria with a whopping 90%. The World Health Organization, estimates that in the year 2010, malaria killed an estimated 660000 people, mostly children. It is estimated by the WHO that a children dies of malaria every minute in Africa. Africa accounts for over a 40% of deaths globally. Hence it is very important and the need of the hour to develop a vaccine against malaria in Africa.
Every professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed. Statistics have confirmed reports that the number of molecules which enter the market to become potential drugs of the future have declined or have become static during the past 10 years. One of the main reasons of failure of drugs is during their initial development cycle wherein pre clinical studies are done on animals, prior to human trials, drug metabolism pathways may differ. To address this issue, a relatively new concept has been introduced by the name of “Microdosing” or Phase 0.
Antibiotic resistance is defined as the infection which does not respond to a particular drug as a result of bacteria changes that make the infection immune to the drug. The drug resistance phenomenon is a huge source of concern with the doctors, physicians and scientists all over the world. If this continues, and if sources are to be believed, then we would not be left with any antibiotics in the next 20 years. If sources are to be believed, we might have soon an antibiotic resistance breaker amongst us as the compound is all set for a phase III trial.
Narrative writing is an important part of Pharmacovigilance and in patient safety as well. Usually patient narratives are written in case of Adverse Events and Serious Adverse Events including deaths. Patient narratives form a very important part of clinical study reports and all other post marketing activities. In case of a Serious Adverse Event it is the Principal Investigator or someone else delegated by he/ she who writes the narrative. A well defined narrative should contain the following points:
The Supreme Court of India has acted upon the DCGI and has made it mandatory for all Multi National Companies and whoever wishes to conduct clinical trials in India to compulsorily video record the informed consent procedure in clinical trials.
So far in the year 2013, at least 573 people have died from Dengue fever in Brazil. This is alarmingly high and twice the figure of deaths than the previous year. A state of alert was declared in several cities in Brazil as the total number of serious reports escalated to 6,566.